Novartis shares dropped 3.3% on Monday morning, according to Reuters reporting, after its cholesterol drug pelacarsen failed in a large, late-stage study by not reducing heart attack and stroke risk in patients with high Lp(a). The setback casts doubt on dedicated Lp(a)-lowering therapies and increases pressure on upcoming data for the Swiss drugmaker’s pipeline.
Pelacarsen Trial Failure Impacts Novartis and Rivals
Late on Friday, Novartis announced that pelacarsen missed its primary goal in patients with high levels of lipoprotein(a), an inherited risk factor that currently lacks approved targeted treatments. Before the trial setback, analysts had forecast peak annual sales between $3 billion and $6 billion for the drug. According to Reuters, the negative data also raises the bar for rival experimental treatments being developed by Amgen and Eli Lilly.
BMO Capital Markets analyst Evan Seigerman wrote in a note that the data marks a meaningful setback for dedicated Lp(a)-lowering therapies. He added that lowering the protein may offer only a modest heart benefit once other standard risk factors like cholesterol are already under control.
Pipeline Pressure Mounts on Muscular Dystrophy Drug
Barclays analysts stated that success in that upcoming trial is needed to justify the $12 billion price Novartis paid to acquire the treatment. Alongside del-desiran, Novartis anticipates data this year from another study evaluating its anti-inflammatory drug remibrutinib in patients with a skin condition called hidradenitis suppurativa.
Despite the pelacarsen setback, Jefferies analysts noted that remibrutinib’s success in a multiple sclerosis trial last week should make the conclusion of the pelacarsen study more palatable for investors.
Did you know? As of Friday’s market close, Novartis shares had gained around a fifth in value so far this year. This growth was driven largely by investor optimism over its broader drug pipeline, even as the company navigates a wave of patent expirations for older medications, according to Reuters reporting.
Frequently Asked Questions
What caused Novartis shares to fall?
Novartis shares fell 3.3% on Monday morning after the company announced late Friday that its cholesterol drug pelacarsen failed to cut heart attack and stroke risk in a late-stage study.
What is Lp(a)?
Lp(a) is an inherited, cholesterol-related risk factor for cardiovascular disease that currently has no approved targeted treatments, according to Reuters.
Which other drug companies are developing Lp(a) treatments?
Amgen and Eli Lilly are both running late-stage trials for their own experimental Lp(a)-lowering drugs, which face a higher bar following the Novartis trial results.
What is the next major pipeline test for Novartis?
Barclays analysts pointed to fourth-quarter data for the experimental muscular dystrophy drug del-desiran as a critical milestone for justifying its acquisition cost.
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